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U.S. Department of Health and Human Services

Class 2 Device Recall SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054010, STERILE

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 Class 2 Device Recall SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054010, STERILEsee related information
Date Initiated by FirmMay 22, 2017
Create DateJanuary 26, 2018
Recall Status1 Terminated 3 on August 29, 2018
Recall NumberZ-0412-2018
Recall Event ID 78687
Product Classification Bit, drill - Product Code HTW
ProductSST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
Code Information LIT 0317305390
FEI Number 2020601
Recalling Firm/
Manufacturer		 MicroAire Surgical Instruments, LLC
3590 Grand Forks Blvd
Charlottesville VA 22911-9006
For Additional Information ContactGlenn Gerstenfeld,
434-975-8000
Manufacturer Reason
for Recall		One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
FDA Determined
Cause 2		Labeling mix-ups
ActionMicroAire Surgical Instruments, LLC distributed recall letters on May 22, 2017 MicroAire Surgical Instruments, LLC distributed recall letters to the customers who received the mislabeled twist. Letters will be sent by UPS to expedite the delivery. For further questions, please call (434) 975-8000
Quantity in Commerce42
DistributionUS Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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